NCT02484690

A Proof-of-Concept Study of Faricimab (RO6867461) in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

A Multiple-Center, Multiple-Dose and Regimen, Randomized, Active Comparator Controlled, Double-Masked, Parallel Group, 36 Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of faricimab (RO6867461) in participants with choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The study was designed to allow the evaluation of RO6867461 in a treatment-naive population (comparison of Arms A, B, C, and D) and an anti-VEGF-incomplete responder population that met a predefined criterion at Week 12 (comparison between Arms A and E). Only one eye per participant was chosen as the study eye.

Conditions

• Choroidal Neovascularization

Interventions

Type	Name	Description
DRUG	Faricimab	Faricimab will be administered as per the regimen specified in the individual arm.
DRUG	Ranibizumab	Ranibizumab will be administered as per the regimen specified in the individual arm.
DRUG	Sham Procedure	The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.

Timeline

• Start date: 2015-08-11
• Primary completion: 2017-09-26
• Completion: 2017-09-26
• First posted: 2015-06-30
• Last updated: 2020-11-12
• Results posted: 2020-10-09

Locations

52 sites across 1 country: United States

Regulatory

• FDA-regulated drug study